Job Description
A Downstream Manufacturing Engineer is required to work with the Days Operations support team to ensure timely delivery of production schedules while maintaining site safety and quality standards.
About PSC Biotech:
- PSC Biotech is a leading biotech consultancy firm founded in 1996.
- Headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US.
- Serving 350 clients in more than 23 countries worldwide.
Our mission is to provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
As a permanent employee, you will have the opportunity to work with top pharmaceutical client sites in a diverse cultural work setting.
**Employee Value Proposition:**
- We empower our employees through Learning & Development, in-house training mentorship, and constant guidance to facilitate career progression.
- We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables.
- We maintain a culture of continuous improvement, staying under budget, and ensuring timelines for our deliverables are being met.
**Role Description:**
As a Downstream Manufacturing Engineer, you will work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure timely delivery of the production schedule while maintaining alignment with site safety and quality standards.
**Key Responsibilities:**
- Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained.
- Own Quality Investigation from identification through root cause analysis.
- Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance, and material management as per area SOPs.
- Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT.
- Act as a link between the shift operations team and days team, ensuring standardization and integration between all IPT teams.
- Support audit readiness in the BDS and drive a permanent audit readiness culture within the team.
- Direct Root Cause Analysis (RCA) sessions for both safety and quality-related events, driving actions to closure with appropriate corrective/preventive measures.
- Drive MPS standards within the area and ensure team alignment on the same.
- Lead/support area change controls, CAPAs, QSAT actions as relevant per work stream as well as completing documentation updates as required.
- Provide ongoing coaching and support to cross-functional team members to share process and operational best practices.
- Act as days operations member on process-centred teams (PCT), working with technical operations and shift operations to identify, perform root cause analysis, and develop corrective/preventative actions for issues as they occur.
**Key Competencies & Experience:**
- A Level 7 Degree in Science, Engineering, or other relevant disciplines/relevant experience.
- At least 3 years' experience in the pharmaceutical industry (preferably in Drug Substance).
- Experiences across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required.
- Experience in change management in a GMP environment.
- Experience in technical writing for GMP documentation and quality investigations.
- Self-motivated with excellent organizational skills.
- Excellent verbal and written communication skills.
- Proficient in Microsoft Office Tools (Word/Excel/PowerPoint).
- Ability to work independently and as part of a team in a cross-functional collaborative environment.
- High level of attention to detail.
- Experience working with GMP Documentation Management Systems.
- Good interpersonal skills.
**Qualifications:**
- At minimum level 7 in a relevant qualification.